In adults with chronic hepatitis C infection, does treating the HCV infection with 12 weeks of a direct acting antiviral combination (Vikera Pak) result in an improvement of endothelial function as measured by reactive hyperaemia peripheral arterial tonometry?

John Hunter Hospital0 个研究点目标入组 16 人开始时间: 2015年11月2日最近更新: 2020年1月13日

适应症

试验速览

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•1.Age >= 18 years
•2.Chronic HCV infection (HCV PCR positive for at least 6 months)
•3.HCV Genotype 1a or 1b
•4.HCV viral load at screening of >=10,000 IU/ml
•5.Absence of advanced fibrosis as defined by fibroscan within 12months prior to randomisation of < 9.6 kPa
•6.Females who are potentially fertile must agree to use 2 forms of reliable contraception

•1. Cirrhosis as defined by any one of
•a.Fibroscan in past 12 months >=12kPa
•b.Liver biopsy in past 5 years showing F4 fibrosis
•c.Clinical or radiological evidence of portal hypertension (any of varices, splenomegaly, reversal of flow in portal vein, ascites, encephalopathy)
•2.Receiving prescribed medication which has a significant interaction with the AbbVie 3D+R regimen which cannot be ceased or substituted
•3.Previous treatment with HCV protease-inhibitor based therapy. (Previous treatment with interferon +/- ribavirin, including both relapsers and null responders is allowed).
•4.Screening laboratory values showing any of:
•a.ALT or AST > 10x ULN
•b.eGFR <60ml/min
•c.Albumin <=30 g/dL
•d.INR >1.3
•e.Haemaglobin <110 g/dL
•f.Platelet count<140 cells/mm3
•g.Total serum bilirubin >2 x ULN
•5.Known latex allergy
•6.Receiving nitrates that cannot be ceased (isosorbide mononitrate, GTN patch)

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